Ocala, FL (May 12, 2015) – Biologic Therapies, a medical device company specializing in the design and development of products for regenerative medicine, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Bio-MAC and Bio-CORE cannulas. The Bio-MAC Bone Marrow Aspiration Cannula and Bio-CORE Bone Marrow Biopsy Cannula are minimally invasive devices that are inserted into bone with any standard surgical drill.
Dr. Wade McKenna, Biologic Therapies’ Chief Medical Director, said, “Unlike traditional bone marrow aspiration cannulas, which are pounded into bone with a mallet or pushed in with brute force, the power driven Bio-MAC and Bio-CORE do not cause microfractures in the bone that can result in pain for the patient. Plus, the Bio-MAC and Bio-CORE are available in multiple lengths, which allow for fast and easy bone marrow draws throughout the anatomy. In addition to the iliac crest and lumbar vertebral body, the tibia, humerus and calcaneus are now viable sites for bone marrow aspiration.
“Our products enable physicians to aspirate bone marrow in their own office with only local anesthesia, which is revolutionary. The ability to aspirate a patient’s marrow, concentrate the marrow in a centrifuge to derive the maximum number of regenerative cells and growth factors, and then give the concentrated cells and growth factors back to the patient in a physician’s office makes regenerative cell therapy a much easier, more available and less costly procedure. The entire point-of-care procedure takes less than 30 minutes. Of course, the Bio-MAC and Bio-CORE are also used in hospitals and surgery centers.”
For concentrating bone marrow Biologic Therapies offers its AUTOSPIN centrifuge and convenience kits. The AUTOSPIN is a fully automated dual spin centrifuge that can be programmed to deliver a volume of 3 to 10 ml from each processing cycle. It is a closed system, which dramatically reduces the chance for contamination. Two separate AUTOSPIN Convenience Kits contain all the components needed to process Bone Marrow Aspirate Concentrate (BMAC) or Platelet-Rich Plasma (PRP).
Luke Whalen, Biologic Therapies’ CEO, said, “My team and I are very pleased to receive 510(k) clearance for our Bio-MAC and Bio-CORE cannulas. We are currently expanding our business throughout the United States, Europe, India, China and South Africa. Biologic Therapies is improving the health of patients around the world by making our products the standard of care for regenerative medicine.”
About Biologic Therapies
Based in Ocala, Florida, Biologic Therapies, Inc. (www.biologictherapies.com) (www.amniotictherapies.com) develops innovative technologies to meet the needs of the emerging regenerative medicine segment of the healthcare market. Biologic Therapies’ mission is to provide groundbreaking medical technologies and procedures that significantly enhance the body’s natural healing ability, thereby providing patients with improved outcomes and quicker restoration of function.